Solid preparation for dialysis and process for producing the same

ABSTRACT

A solid preparation for dialysis for preparing a double preparation type sodium bicarbonate solid preparation for dialysis in which there is no fear that a sugar is decomposed or colored, and which can maintain stability and also is excellent in content homogeneity and a process for producing the same. The solid preparation for dialysis is a mixture of a first composition composed of core particles including sodium chloride that are coated with a coating layer containing one or more electrolytes, a second composition composed of core particles including a sugar that are covered with a coating layer containing one or more electrolytes, and an acid.

FIELD OF THE INVENTION

The present invention relates to a solid preparation for dialysis foruse in preparing a dialysate containing sodium bicarbonate. That is, thepresent invention relates to a solid preparation containingelectrolytes, an acid and a sugar, which is to be used in sodiumbicarbonate solid preparations for dialysis which usually comprise twopreparations. These are a preparation containing sodium bicarbonate inaddition to a preparation containing electrolytes, an acid, and a sugarand not containing sodium bicarbonate (hereinafter referred to as adouble preparation type sodium bicarbonate solid preparation fordialysis).

BACKGROUND OF THE INVENTION

When hemodialysis is carried out for a patient having decreased kidneyfunction, the blood of the patient is purified in an artificial kidney.A dialysate is perfused inside of this artificial kidney, and wasteproducts in the blood are generally transferred into the dialysatethrough a dialysis membrane. As this dialysate, acetic acid-containingdialysate has widely been used. In recent years, however, it has beensubstituted by a dialysate using sodium bicarbonate that remarkablyreduces discomfort during the hemodialysis.

The dialysate containing sodium bicarbonate is usually prepared from twokinds of dialysate preparations, one being a liquid preparationcontaining electrolyte components (for example, sodium chloride,potassium chloride, calcium chloride, magnesium chloride, and sodiumacetate) and a pH adjusting agent (for example, acetic acid)(hereinafter referred to as liquid A preparation), and the other being aliquid preparation containing sodium bicarbonate (hereinafter referredto as liquid B preparation). The dialysate preparations sometimescontain a sugar such as glucose, or another preparation containing asugar is mixed with these dialysate preparations.

The liquid A preparation and the liquid B preparation have hitherto beensold in the form of dense liquids prepared at a predeterminedconcentration, and users have diluted them with water for use. However,since about 300 liters of a dialysate is needed for one patient for onedialysis, in the case of conducting dialysis treatments for manypatients, a large quantity of a dense liquid is used, and dilution of itwith water is needed. Thus, in order to relieve a burden on people whoprepare a dialysate, and to save space, cases using a B preparation thatis pulverized have increased. A double preparation type sodiumbicarbonate solid preparation for dialysis in which the A preparation isalso pulverized has also been recently developed.

As a pulverized double preparation type sodium bicarbonate solidpreparation for dialysis, a preparation for dialysis that comprises twocompositions, that is, one powdery preparation (A preparation)comprising electrolytes (except for sodium bicarbonate), glucose and aliquid acid, and another powdery preparation (B preparation) comprisingonly sodium bicarbonate, or sodium bicarbonate and sodium acetate orglucose, has been disclosed (Japanese Patent Publication No. 2749375 andNo. 2751933, and Japanese Patent Unexamined Publication No. Hei3-38527).

Among these preparations for dialysis, either a dry method or afluidized bed method is used to produce the A preparation. The drymethod comprises stirring and mixing electrolytes except for sodiumbicarbonate and glucose using a stirring mixer, subsequently pulverizingthe mixture using a pulverizer, after that mixing the mixture again, andafter granulating the mixture using a dry granulator, mixing thegranulated mixture with a liquid acid. Moreover, the fluidized bedmethod comprises mixing sodium chloride and glucose using a stirringmixer, and, after granulating the mixture while spraying the mixture ina fluidized bed granulator with an aqueous solution obtained bydissolving electrolytes except for sodium chloride and sodiumbicarbonate into water, mixing them with a liquid acid.

However, in a preparation for dialysis that is obtained by the methodsdescribed above, glucose is likely to be decomposed or colored becausetime for heating glucose during the production process is long. Thus ithas been generally considered that a double preparation type sodiumbicarbonate solid preparation for dialysis in which the A preparationcontains glucose has a shortened period of time for maintainingstability as compared with a sodium bicarbonate solid preparation fordialysis comprising three preparations where glucose is separatelyprovided. Furthermore, it is difficult to achieve content homogeneity ina double preparation type sodium bicarbonate solid preparation fordialysis that is obtained by the methods described above.

SUMMARY OF THE INVENTION

In view of the above circumstances, it is an object of the presentinvention to provide a solid preparation for dialysis containingelectrolytes (except for sodium bicarbonate), an acid and a sugar. Thepreparation can maintain stability equal to a sodium bicarbonate solidpreparation for dialysis comprising three preparations where a sugar isseparately provided, is excellent in content homogeneity and there is nofear that the sugar is decomposed or colored.

In order to solve the above problems, the present inventorswholeheartedly investigated. They found out that the desired object canbe achieved by granulating a composition containing electrolytes exceptfor sodium bicarbonate and a composition containing a sugar separatelyand subsequently mixing them with an acid to produce an A preparation ofa double preparation type sodium bicarbonate solid preparation fordialysis, and attained the present invention.

That is, the present invention is a solid preparation for dialysiscomprising a mixture of particles of a first composition containing oneor more electrolytes selected from the group consisting of sodiumchloride, calcium chloride, magnesium chloride, potassium chloride andsodium acetate, particles of a second composition containing a sugar andone or more electrolytes selected from the group consisting of sodiumchloride, calcium chloride, magnesium chloride, potassium chloride andsodium acetate, and an acid.

Further, the present invention is a process for producing a solidpreparation for dialysis comprising the following steps (1) to (3):

(1) a step of spraying an aqueous solution containing one or moreelectrolytes selected from the group consisting of calcium chloride,magnesium chloride, potassium chloride and sodium acetate onto coreparticles containing sodium chloride, and drying the coated particles toobtain a first composition;

(2) a step of spraying an aqueous solution containing one or moreelectrolytes selected from the group consisting of sodium chloride,calcium chloride, magnesium chloride, potassium chloride and sodiumacetate onto core particles containing a sugar, and drying the coatedparticles to obtain a second composition; and

(3) a step of mixing the first composition obtained in step (1) and thesecond composition obtained in step (2), and further mixing them with anacid to obtain the solid preparation for dialysis.

Moreover, the present invention is a process for producing a solidpreparation for dialysis comprising the following steps (1) to (3):

(1) a step of spraying an aqueous solution containing one or moreelectrolytes selected from the group consisting of calcium chloride,magnesium chloride, potassium chloride and sodium acetate onto coreparticles containing sodium chloride, and drying the coated particles toobtain a first composition;

(2) a step of spraying an aqueous solution containing one or moreelectrolytes selected from the group consisting of sodium chloride,calcium chloride, magnesium chloride, potassium chloride and sodiumacetate onto core particles containing a sugar, and drying the coatedparticles to obtain a second composition; and

(3) a step of mixing an acid with the first composition obtained in step(1), and subsequently mixing the resultant mixture with the secondcomposition obtained in step (2) to obtain the solid preparation fordialysis.

DETAILED DESCRIPTION OF THE INVENTION

The first composition of the solid preparation for dialysis preferablyhas a characteristic feature that core particles containing sodiumchloride are covered with a coating layer containing one or moreelectrolytes selected from the group consisting of calcium chloride,magnesium chloride, potassium chloride and sodium acetate.

Moreover, the second composition of the solid preparation for dialysispreferably has a characteristic feature that core particles containing asugar are covered with a coating layer containing one or moreelectrolytes selected from the group consisting of sodium chloride,calcium chloride, magnesium chloride, potassium chloride and sodiumacetate.

Sodium chloride of the core particles forming the first composition maybe any one as long as it is in the solid state and forms core particles,and sodium chloride having a particle diameter of about 75 to 1,700 μmand which is in a crystalline state is preferable.

The core particles may include particles of an electrolyte such asmagnesium chloride, calcium chloride, potassium chloride, sodium acetateor the like in addition to sodium chloride. The content of theelectrolyte particles in the core particles is at most 15% by weight. Onproducing the first composition of the present invention, theelectrolyte may be used as it is without being pulverized. Also, inadvance, the electrolyte may be pulverized into particles having aparticle diameter of 75 to 1,700 μm by a pulverizer or a particle sizeselector, or may be granulated into granules having a similar size bywet or dry granulation.

The coating layer of the particles forming the above first compositioncontains one or more electrolytes selected from the group consisting ofcalcium chloride, magnesium chloride, potassium chloride and sodiumacetate. Moreover, the electrolytes may contain sodium chloride inaddition to the above components. The content of sodium chlorideincluded in the coating layer is at most 50% by weight.

As the calcium chloride, calcium chloride dihydrate, calcium chloridemonohydrate, calcium chloride anhydride or the like is used. As themagnesium chloride, magnesium chloride hexahydrate or the like ispreferably used. As the sodium acetate, sodium acetate anhydride, sodiumacetate trihydrate or the like is preferably used.

The electrolytes contained in the coating layer of the first compositionare used to form a coating layer on the core particles by dissolving theelectrolytes in water to prepare an aqueous solution, spraying thesolution onto the core particles of the first composition, and dryingthe particles. The concentration of the electrolytes in the aqueoussolution is preferably 15 to 50% by weight and more preferably 25 to 40%by weight. If the concentration of the aqueous solution is lower than15% by weight, it takes a longer time to coat the core particles sincethe quantity of the aqueous solution becomes greater. If theconcentration of the aqueous solution is higher than 50% by weight, theelectrolytes are not fully dissolved into the water and there is a fearthat a suspension will be formed.

As the sugar of the core particles forming the above second composition,glucose, maltose, xylitol, trehalose or the like is used. Glucose ispreferably used. The sugar is preferably a powder having a particlediameter of about 45 to 1,700 μm.

The core particles may include particles of an electrolyte such assodium chloride, magnesium chloride, calcium chloride, potassiumchloride, sodium acetate or the like in addition to the sugar component.The content of the particles of electrolyte in the core particles is atmost 50% by weight. On producing the second composition of the presentinvention, the electrolyte may be used as it is without beingpulverized. Moreover, in advance, the electrolyte may be pulverized intoparticles having a particle diameter of 75 to 1,700 μm by a pulverizeror a particle size selector, or may be granulated into granules having asimilar size by wet or dry granulation.

The coating layer of the particles forming the above second compositioncontains one or more electrolytes selected from the group consisting ofsodium chloride, calcium chloride, magnesium chloride, potassiumchloride and sodium acetate. The electrolytes are used to form a coatinglayer on the core particles by dissolving the electrolytes into water toprepare an aqueous solution, spraying the solution onto the coreparticles containing the sugar component, and drying the particles. Theconcentration of the sugar component in the aqueous solution ispreferably 1 to 60% by weight, and more preferably 15 to 40% by weight.Moreover, the coating layer may contain glucose in addition to theelectrolytes. The content of the glucose in the coating layer is at most50% by weight.

The first composition and the second composition of the solidpreparation for dialysis of the present invention can be obtained bygranulation according to a centrifugal fluidized bed granulation method,a fluidized bed granulation method, an agitating fluidized bedgranulation method or the like. For both the first composition and thesecond composition, an agitating fluidized bed granulation method ispreferably used. The first composition and the second composition aregranulated by the above granulation methods into granules having anaverage particle diameter of 300 to 1,700 μm. By this process, the firstcomposition and the second composition can be mixed homogeneously, and asolid preparation for dialysis that is excellent in homogeneity can beobtained.

An agitating fluidized bed granulation apparatus is used for theagitating fluidized bed granulation method. The agitating fluidized bedgranulation apparatus is an apparatus in which the core particles areagitated and fluidized by a fluidizing action of an airflow from thevicinity of the wall and an agitating action by rotation of a rotator inthe bottom of the apparatus, and an aqueous solution containing acomponent forming the coating layer is sprayed to form a homogeneouscoating layer on the core particles.

The flow rate of the airflow is preferably 0.2 to 300 m³/min, morepreferably, 0.5 to 200 m³/min. If the flow rate is less than 0.2 m³/min,the core particles are likely to form aggregates with one another.Moreover, if the flow rate is greater than 300 m³/min, the components inthe aqueous solution are apt to cause a spray dry phenomenon and,furthermore, fine powders are likely to be formed since impact ofparticles becomes greater.

Furthermore, the rate of revolution of the rotor is preferably 20 to1,000 rpm and, more preferably, 50 to 500 rpm. If the rate of revolutionis smaller than 20 rpm, the thickness of the coating layer becomesnonhomogeneous. moreover, if the rate of revolution is greater than1,000 rpm, there is a fear that the coating layer will be scraped offbecause of mutual collision of the coated particles and friction of thecoated particles with the inner wall of the apparatus.

Drying is carried out continuously during the above spraying at anexhaust gas temperature of 25 to 70° C.; preferably, 30 to 60° C. Thewater content of the granulated product after drying is preferably 0 to10%.

The first composition and the second composition are charged into aV-type mixer or the like, and an acid is further added and thecomponents are mixed to form a solid preparation for dialysis. Examplesof the above acid include acetic acid, hydrochloric acid, lactic acidand the like. Acetic acid is most preferably used among them. The aboveacid may include a solid acid such as citric acid, oxalic acid or thelike, if necessary.

The order of mixing is preferably (1) mixing the first composition andthe second composition, and further mixing the acid, or (2) mixing thefirst composition and the acid, and further mixing the secondcomposition, for the purpose of preventing volatilization of the acid,and in order to react the acid and sodium acetate rapidly. When mixingis carried out in the above order (1), the acid is preferably addedsimultaneously when the first composition and the second composition aremixed, or is added just after mixing of the first composition and thesecond composition.

The solid preparation for dialysis of the present invention is used toform a dialysate by mixing it with a solid preparation containing sodiumbicarbonate at a predetermined mixing ratio and subsequently dissolvingthe mixture into water. Moreover, after the above solid preparation fordialysis and sodium bicarbonate are respectively dissolved into water tomake two aqueous solutions, the two solutions may be mixed to prepare adialysate. Furthermore, after the above solid preparation for dialysisor sodium bicarbonate is dissolved into water to make an aqueoussolution, the remaining preparation may be dissolved into the solutionto prepare a dialysate.

When the solid preparation for dialysis of the present invention isdissolved together with sodium bicarbonate into water to prepare adialysate, the dialysate has, for example, the following composition.

Na⁺ 120 to 150 mEq/L K⁺ 0.5 to 3 mEq/L Ca²⁺ 1.5 to 4.5 mEq/L Mg²⁺ 0.1 to2.0 mEq/L Cl⁻ 90 to 135 mEq/L CH₃COO⁻ 5 to 15 mEq/L HCO₃ ⁻ 20 to 35mEq/L Glucose 0.5 to 2.5 g/L

The dialysate having the above composition preferably has a pH value of7.2 to 7.4.

EXAMPLES

Hereinafter, the present invention is illustrated in more be detail byusing examples. However, the present invention is not limited to theseexamples.

Example 1

Into 519.9 g of purified water, 36.6 g of potassium chloride, 25.0 g ofmagnesium chloride hexahydrate, 45.1 g of calcium chloride dihydrate and110.8 g of sodium acetate anhydride were dissolved to prepare an aqueoussolution. Into an agitating fluidized bed granulation apparatus(Multiplex MP-01, produced by Powrex Co., Ltd.), 1, 500 g of sodiumchloride having an average particle diameter of 300 μm as core particleswere charged. Under the conditions of an air feed temperature of 80° C.,a rotor revolution rate of 300 rpm and an air feed flow rate of 40m³/hr, the above aqueous solution was sprayed onto the core particlesand dried at the same time to obtain granules of a first compositionhaving an average particle diameter of 850 μm.

Separately, 77.8 g of sodium chloride, 10.4 g of potassium chloride, 7.1g of magnesium chloride hexahydrate, 12.9 g of calcium chloridedihydrate and 31.6 g of sodium acetate anhydride were dissolved into334.0 g of purified water to prepare an aqueous solution. Into anagitating fluidized bed granulation apparatus (Multiplex MP-01, producedby Powrex Co., Ltd.), 700.0 g of glucose having an average particlediameter of 180 μm and 349.7 g of sodium chloride as core particles werecharged. Under the conditions of an air feed temperature of 60° C.,rotor revolution rate of 200 rpm and an air feed flow rate of 40 m³/hr,the above aqueous solution was sprayed onto the core particles and driedat the same time to obtain granules of a second composition having anaverage particle diameter of 850 μm.

Next, 236.2 g of the granules of the first composition and 63.8 g of thegranules of the second composition, which were cooled down to roomtemperature, were charged into a V-type mixer (S-3 type, produced byTsutsui Rikagakukikai Co., Ltd.). Then, 5.64 g of glacial acetic acidwere further added into the mixer and mixed homogeneously to obtain asolid preparation for dialysis having an average particle diameter of850 μm.

Example 2

In the same manner as in Example 1, granules of a first composition andgranules of a second composition each having an average particlediameter of 850 μm were obtained. Into a V-type mixer (S-3 type,produced by Tsutsui Rikagakukikai Co., Ltd.), 300.0 g of the granules ofthe first composition that was cooled down to room temperature werecharged, and 6.44 g of glacial acetic acid were further added into themixer, and the mixture was mixed. Subsequently, after the above mixturewas taken out from inside of the mixer, 241.8 g of the mixture and 63.8g of the granules of the second composition were charged into the V-typemixer, and mixing was carried out homogeneously to obtain a solidpreparation for dialysis having an average particle diameter of 850 μm.

Comparative Example 1

Into an agitating mixer apparatus (vertical granulator VG-25, producedby Powrex Co., Ltd.), 3,000 g of sodium chloride, 73.3 g of potassiumchloride, 49.9 g of magnesium chloride hexahydrate, 90.3 g of calciumchloride dihydrate, 221.6 g of sodium acetate anhydride and 491.2 g ofglucose were charged. After mixing the mixture for ten minutes, 190 g ofpurified water were added to the mixture and the mixture was furthermixed for 20 minutes. The composition thus obtained was placed into afluidized dryer, and it was dried at 50° C. for one hour. The abovecomposition, which was cooled down to room temperature, was charged intoa V-type mixer (S-3 type, produced by Tsutsui Rikagakukikai Co., Ltd.),and 5.6 g of glacial acetic acid were further added into the mixer.Mixing was carried out homogeneously to obtain a solid preparation fordialysis having an average particle diameter of 350 μm.

Comparative Example 2

Into an agitating mixer apparatus (vertical granulator VG-25, producedby Powrex Co., Ltd.), 3,000 g of sodium chloride, 73.3 g of potassiumchloride, 49.9 g of magnesium chloride hexahydrate, 90.3 g of calciumchloride dihydrate, 221.6 g of sodium acetate anhydride and 491.2 g ofglucose were charged. After mixing the mixture for ten minutes, themixture thus obtained was charged into a pulverizer (SW-1, produced byPowrex Co., Ltd.) to pulverize to an average particle diameter of 50 μm.Then, granulation was conducted by a roller compactor to obtain acomposition having an average particle diameter of 500 μm. Subsequently,300.0 g of the above composition were charged into a V-type mixer (S-3type, produced by Tsutsui Rikagakukikai Co., Ltd.), and 5.6 g of glacialacetic acid were further added into the mixer. Mixing was carried outhomogeneously to obtain a solid preparation for dialysis having anaverage particle diameter of 500 μm.

Test Results

With respect to the solid preparations for dialysis that were obtainedin the above Examples 1 and 2 and Comparative Examples 1 and 2, contentmeasurement of electrolytes, acetic acid, and glucose, evaluation ofcontent homogeneity, and a stability test were carried out.

Content Measurement, Evaluation of Homogeneity

From each of the solid preparations for dialysis that were obtained inthe above Examples 1 and 2 and Comparative Examples 1 and 2, 50 g of asample were arbitrarily taken out six times, and the respective sampleswere dissolved into water to prepare 500 ml of an aqueous solution. Thecontent of each component in the aqueous solution was measured. Theproportion (%) of the average of the measured contents to thetheoretical values and CV values (%) (coefficient of variation) areshown in Table 1.

In the content measurement, Na and K were measured with a flamephotometer, Ca and Mg were measured by ion chromatography, acetic ion(AcO⁻) and citric acid were measured with HPLC-UV, Cl was measured by asilver nitrate titration method, and glucose was measured with apolarimeter.

TABLE 1 Comparative Comparative Example 1 Example 2 Example 1 Example 2Content CV value Content CV value Content CV value Content CV valueComponent (%) (%) (%) (%) (%) (%) (%) (%) Na⁺ 99.4 0.4 99.6 0.3 97.4 4.398.6 3.9 K⁺ 98.9 0.6 99.0 0.6 95.3 3.2 95.1 4.0 Ca²⁺ 99.8 0.8 100.5 0.8102.8 3.1 99.3 2.9 Mg²⁺ 100.3 1.1 101.0 0.8 98.0 2.9 97.9 2.5 AcO⁻ 99.50.5 99.6 0.6 97.2 3.0 97.7 3.2 Cl⁻ 100.2 0.2 100.6 0.3 98.0 4.1 99.3 2.2Glucose 99.0 1.1 99.1 1.0 131.5 20.8 110.9 12.9 Content (%) = (averageof the measured contents) / (the theoretical value) × 100 (%)

As is apparent from Table 1, in the solid preparation for dialysis ofthe present invention the averages of the respective contents are closeto the theoretical values, CV value is also small, and contenthomogeneity is excellent. On the other hand, the solid preparation fordialysis that is obtained by a wet granulation method in ComparativeExample 1 and the solid preparation for dialysis that is obtained by adry granulation method in Comparative Example 2 each had anonhomogeneous content of glucose.

Stability Test

In a 100×100 mm aluminum wrapping material, 50 g of a sample of therespective solid preparations for dialysis that were obtained in theabove Examples 1 and 2 and Comparative Examples 1 and 2 were enclosed.In the samples that were preserved (A) at 25° C., 60% RH for six months,or (B) at 40° C., 75% RH for three months, coloration of the solidpreparations for dialysis in the wrapping material was measured with acolor-difference meter (Z-300A, produced by Nippon Denshoku Co., Ltd.).The results are shown in Table 2.

TABLE 2 coloration just coloration after preservation after production(A) (B) Example 1 none none none Example 2 none none none Comparativenone colored colored Example 1 Comparative none none none Example 2

As is apparent from Table 2, the solid preparation for dialysis of thepresent invention shows no coloration after a long-term preservation. Onthe other hand, the solid preparation for dialysis that is produced bythe wet granulation method in Comparative Example 1 showed colorationafter preservation.

Advantageous Effect of the Invention

According to the present invention, a solid preparation for dialysisthat is excellent in content homogeneity can be provided by granulatingseparately a composition comprising electrolytes except for sodiumbicarbonate and a composition comprising a sugar, and then mixing thecompositions with an acid to produce the A preparation of a doublepreparation type sodium bicarbonate solid preparation. Moreover, a solidpreparation for dialysis that shows no decomposition and coloration ofglucose and is excellent in long-term preservation stability can beobtained.

What is claimed is:
 1. A solid preparation for dialysis comprising amixture of (a) a first composition which comprises core particlescomprising particles of sodium chloride and a coating layer covering thecore particles and containing one or more electrolytes selected from thegroup consisting of calcium chloride, magnesium chloride, potassiumchloride and sodium acetate, (b) particles of a second composition whichcomprises core particles comprising particles of a sugar and a coatinglayer covering the core particles and containing one or moreelectrolytes selected from the group consisting of sodium chloride,calcium chloride, magnesium chloride, potassium chloride and sodiumacetate, and (c) an acid.
 2. The solid preparation for dialysis asclaimed in claim 1, wherein the acid is acetic acid, hydrochloric acidor lactic acid.
 3. The solid preparation for dialysis as claimed inclaim 1, wherein the first composition is granulated into granuleshaving an average particle diameter of 300 to 1,700 μm and the secondcomposition is granulated into granules having an average particlediameter of 300 to 1,700 μm.
 4. A sodium bicarbonate solid preparationfor dialysis comprising the solid preparation for dialysis claimed inclaim 1 and a solid preparation containing sodium bicarbonate.
 5. Thesolid preparation for dialysis as claimed in claim 1, wherein the coreparticles of the first composition include up to 15% by weight, based onthe weight of the core particles, of particles of an electrolyteselected from the group consisting of magnesium chloride, calciumchloride, potassium chloride and sodium acetate.
 6. The solidpreparation for dialysis as claimed in claim 1, wherein the coreparticles of the second composition include up to 50% by weight, basedon the weight of the core particles, of particles of an electrolyteselected from the group consisting of sodium chloride, magnesiumchloride, calcium chloride, potassium chloride and sodium acetate. 7.The solid preparation for dialysis as claimed in claim 1, wherein thecoating layer of the first composition further comprises up to 50% byweight, based on the weight of the coating layer, of sodium chloride. 8.The solid preparation for dialysis as claimed in claim 1, wherein thecoating layer of the second composition further comprises up to 50% byweight, based on the weight of the coating layer, of glucose.